Clinical Research Coordinator Resume Example

Coordinate 5 concurrent Phase II-III oncology and cardiology clinical trials involving 180+ participants, ensuring 98% protocol compliance and zero major audit findingsManage patient recruitment strategies that exceeded enrollment targets by 35%, reducing study timeline by 4 monthsConduct informed consent procedures, screen participants for eligibility, and coordinate study visits while maintaining detailed source documentationServe as primary liaison between principal investigators, sponsors, CROs, and regulatory bodies, facilitating seamless communication across 8 study sitesPrepare and submit regulatory documents including IRB submissions, amendments, and continuing reviews with 100% on-time approval rateTrain and mentor 3 junior coordinators on GCP guidelines, protocol procedures, and electronic data capture systems (Medidata Rave, REDCap)

Coordinated 4 Phase I-II clinical trials in neurology and metabolic disorders, managing 75+ study participants from screening through follow-upAchieved 92% participant retention rate through proactive communication and relationship management strategiesMaintained regulatory binders and essential documents in accordance with FDA and ICH-GCP requirements, passing 3 sponsor audits with zero findingsCollected, processed, and shipped biological specimens to central laboratories while ensuring proper chain of custody and temperature monitoringCollaborated with pharmacy to manage investigational product accountability, storage, and dispensing per protocol requirements

Supported 6 clinical research coordinators in managing cardiovascular and diabetes studies with 200+ active participantsScheduled and coordinated 500+ study visits, procedures, and assessments while maintaining detailed calendars and remindersPerformed data entry into EDC systems with 99.5% accuracy rate and resolved data queries within 48-hour turnaround timeAssisted with regulatory document preparation, study supply inventory management, and adverse event reportingConducted phone screenings and pre-screening activities, qualifying 150+ potential participants for study enrollment